Effect of epidural balloon neuroplasty with hyaluronidase on epidural adhesion lysis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011817

Enrollment

150

Registered

2026-04-06

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : The Tergase group undergoes epidural balloon neuroplasty with hyaluronidase. In epidural balloon neuroplasty with hyaluronidase, when the balloon catheter fails to pass through the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged = 20 and < 80 years 2. Central canal stenosis at L4-5 or L5-S1 confirmed on magnetic resonance imaging (MRI) 3. Lower extremity radicular pain with a Numerical Rating Scale (NRS) score = 6, regardless of low back pain 4. Chronic lower extremity radicular pain refractory to non-invasive conservative treatment for = 3 months 5. < 50% reduction in lower extremity radicular pain, or analgesic duration < 1 month, following epidural nerve block 6. Epidural adhesion: filling defect confirmed in the epidural space of the central spinal canal at L4-5 or L5-S1 on epidurogram 7. Failure of the catheter to pass through the filling defect on the first attempt during the balloon neuroplasty procedure 8. Patients who want to participate in this study and write informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1. Concomitant central canal stenosis at L3-4 or above 2. Concomitant foraminal stenosis 3. Degenerative lumbar spondylolisthesis of Meyerding grade = II 4. Scoliosis with a Cobb angle = 30° 5. History of previous lumbar spine surgery 6. Contraindications to nerve block, including coagulopathy, active infection, or antiplatelet agent use 7. Uncontrolled use of opioid analgesics 8. Known allergy or adverse reaction to contrast medium, local anesthetics, steroids, or hyaluronidase 9. Pregnancy or lactation 10. Uncontrolled medical or psychiatric comorbidities 11. Patient refusal to participate in this study 12. Inadvertent catheter migration from the anterior to the posterior epidural space, or from the posterior to the anterior epidural space, during catheter advancement

Design outcomes

Primary

Measure	Time frame
Rate of catheter insertion success within 5 minutes of re-entry attempts	—

Secondary

Measure	Time frame
Time from drug administration (i.e., start of re-entry) to catheter insertion success;Operator-assessed procedural difficulty in catheter passage through the filling defect;Pain intensity of leg pain (Numerical Rating Scale, NRS, 0–10);Pain intensity of back pain (Numerical Rating Scale, NRS, 0–10);Adverse event related to the allocated intervention;Co-intervention during follow-up period (up to 1 month after the intervention)	—

Measure

Time frame

Time from drug administration (i.e., start of re-entry) to catheter insertion success;Operator-assessed procedural difficulty in catheter passage through the filling defect;Pain intensity of leg pain (Numerical Rating Scale, NRS, 0–10);Pain intensity of back pain (Numerical Rating Scale, NRS, 0–10);Adverse event related to the allocated intervention;Co-intervention during follow-up period (up to 1 month after the intervention)

—

Countries

Korea, Republic of

Contacts

Public ContactChan-Sik Kim

Asan Medical Center

chansik.kim86@gmail.com+82-2-3010-3868

Outcome results